Clinical trial NCT05262920: Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Official title: Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Pain, Acute
Maternal Distress
Parent-Child Relations
Self Efficacy
Keywords: breastfeeding, pain, self-efficacy
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Hartford HealthCare
name: UConn Health
name: National Institute of Nursing Research (NINR)
First posted: 2022-03-02
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed RCT will be conducted to test the effect of the BSM intervention vs. an attention control group on BNP, BF exclusivity and duration, BF self-efficacy, and maternal well-being to 24 weeks
Primary purpose: TREATMENT

Brief summary: Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal well-being and infant's health, physical growth, and development. The highest rate of BF cessation occurs within 3 weeks after birth, with 30% of women ceasing BF due to acute breast and nipple pain (BNP). BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signalling that stimulates multiple pain pathways. Women who experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months, increased maternal distress symptoms, and may differ across races contributing to differences in early BF cessation rates. The investigators developed and tested a 6-week nurse-led and participant-informed, Breastfeeding and Breast and Nipple Pain Self-Management (BSM) intervention guided by the Individual and Family Self-Management Theory. Aligned with the needs and preferences elicited from a diverse sample of BF participants, the investigators used a cloud-based platform, to deliver BF knowledge and skills, and provided support through nurse-led text-based communication to decrease BNP, increase BF self-efficacy, decrease burdensome face-to-face visits, and increase adaptive coping behaviors. Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. Based on these promising results, the investigators propose to examine the efficacy of the BSM intervention in an R56 RCT, Promoting Self-Management of Breast and Nipple Pain Using Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity. The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants, how participants' pain sensitivity affects BNP. The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, pain, pain coping, and maternal self-efficacy, on BF exclusivity. Participants (N = 222) intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks. Study results will advance knowledge on the BSM intervention, with direct implications for nurse-designed and led self-management interventions in clinical settings or health care systems.

Detailed description: In response to the critical gap that exists in identifying effective biobehavioral self-management interventions for participants during BF initiation who experience breast and nipple pain (BNP), the investigators developed a patient-informed Breastfeeding and BNP Self-Management (BSM) intervention based on the Individual and Family Self-Management Theory. The investigators propose to test the effectiveness of the BSM intervention on BNP severity, pain interference with daily life, and BF outcomes over time in this R56 RCT, Promoting Self-Management of Breast and Nipple Pain with Technology (PROMPT) for Breastfeeding Women. Participants (N=222) intending to BF will be randomized either to receive the BSM intervention or be in the attention control group, with assessments performed after birth at the hospital (baseline). After screening and informed consent, participants will be asked to complete study measures, undergo quantitative sensory testing using a standardized protocol, and access a secure electronic survey site via participants' smartphone or study-provided smartphone text links or email before discharge home. During the first week home, all participants will receive bi-weekly texts with links to BSM intervention BF modules or for the attention control group, educational modules on postpartum recovery and infant care. All participants at 1, 2, 3, 9, 12, and 18 weeks will receive a text or email for ongoing assessments of BNP and BF measures of the exclusivity (breast, breast milk, or formula), the number of feedings each day, and how long (days/weeks/months) infants were breastfed (duration). In addition, the study occurs via mobile technology during an acute period of pain when the rate of BF cessation is the highest. At 6- and 24-weeks participants will repeat the study measures and quantitative sensory testing.

The PROMPT study is the first to target self-management for BNP using cloud-based educational modules and user-preferred text-based smartphone intervention during the critical weeks of BF initiation, when support for BF is most desired, face-to-face visits are most burdensome, and places the mother-infant dyads at risk for illness, such as COVID-19. The study will describe how many participants experience BNP from BF initiation to 24 weeks as participants return to work and who may be at risk for chronic pain, which has not been examined. The study also replicates and expands on how the presence of pain sensitivity affects BNP and BF outcomes. The results from this study hold great promise to 1) support a diverse population of BF participants by identifying the risk factors of BNP; 2) target personal interventions for participants experiencing BNP based on unique moderating factors of pain sensitivity, nonpharmacological interventions, BF self-efficacy, pain coping, maternal self-efficacy and maternal well-being (anxiety, depression, stress, and fatigue); and 3) to develop easily accessible strategies for participants BF within clinical settings that allow for large-scale translation in health care systems or public health settings.

Participant Recruitment will begin by active and passive methods successfully used in the pilot study with the addition of prenatal recruitment in the clinical site. Passive methods include (1) advertisements via Facebook pages (Connecticut Breastfeeding Coalition and the School of Nursing Center for the Advancement of Management of Pain (CAMP)) and Instagram ads, targeting participants in Connecticut who intend to BF, (2) flyers posted at clinical partners offices, (3) flyers given by the clinical partners to participants expressing interest in BF during routine prenatal care and referring participants to the peer counselors, research assistants, or lactation consultants team members on the inpatient hospital units, (4) flyers included in discharge educational packets at both recruitment sites, (5) flyers posted in hospital (HH, UConn Health) common areas.

Active methods include screening the inpatient unit census two to three times per week by the clinical partners for participants who meet inclusion or exclusion criteria. Participants who agree to speak with a member of the research team about the study will be approached. A HIPAA consent will be obtained for the research team to ask initial screening questions via REDCap (Research Electronic Data Capture). REDCap is a secure web application and database storage for creating and managing online data collection with highly customizable data types (including 21 CFR Part 11, FISMA, and HIPAA-compliant environments). If eligible, informed consent will be obtained by a member of the research team trained in obtaining informed consent and approved by the IRB.

The investigators will recruit participants after birth, with data collection to occur before discharge from the hospital and take approximately 60 minutes. To decrease participant burden, recruitment will begin during the antenatal care so participants may anticipate participating in data collection after delivery. In BSM pilot study, the retention rate was 94% of participants at 6 weeks, and as the primary aim is the effectiveness of the intervention during the first 3 weeks, the sample size calculations account for the possibility of loss-to-follow-up as high as 5% at 3 weeks. Additionally, the investigators anticipate the possibility of a 25% attrition rate at 24 weeks, a level somewhat larger than the 15-20% rate observed in many longitudinal intervention trials.

After informed consent and prior to the start of data collection, participants will be randomized to the BSM intervention or the attention control group and be assigned a unique participant identification number. Participants will be shown how to access the REDCap modules on participants' or a study-provided smartphone. An alternative contact person's information will be requested to reduce the likelihood of attrition. A randomization schedule created in REDCap will ensure that the two groups remain balanced with respect to age, race, BF experience, antenatal plan for BF duration, route of delivery, and intent to return to work. The randomization assignment will be known to data management graduate assistant with experience in clinical trials, intervention monitoring, IRB compliance. The PI will be blinded to the randomization assignment of participants. The graduate assistant will not be involved in data collection but will administer and monitor the interventions and missing data.

After discharge, both groups will receive an encrypted text via REDCap with embedded links from Twilio, a cloud communications platform, and a backup archive feature to secure participant's privacy and confidentiality, from the nurse on the research team. The follow-up measures at 1, 2, 3, 9, 12, and 18 weeks (Figure 4, see research plan) include the participants weekly BNP, pain coping, BF exclusivity, ongoing BF assessment, BF algorithm, and maternal assessment of infant BF behaviors, self-efficacy scales (pain, BF, and maternal), maternal well-being assessments, and perceived well-being scales. The completion of the measures will take about 30 minutes. Weekly meetings will identify any missing data and contact participants to complete the surveys. At 6 and 24 weeks, participants will complete the above measures and quantitative sensory testing at the clinical locations. The completion of the measures will take about 60 minutes.

Intervention Administration. Each group will receive a link to the eight video modules that address a different topic within a 15-minute interval. During the first week, the appropriate link to the first video to the BSM intervention and attention control group will be sent. Intervention fidelity will be addressed using continual assessment of design, training, delivery, receipt, enactment throughout the study duration. Design fidelity is applied through a standardized intervention with scheduled interactive texts, text-based daily BF journals and links to modules. Dr. Lucas will routinely assess the training of the interventionist(s) through simulated scenarios and practice sessions using texting and phone scripts. Evidence of treatment will include participant's response to bi-weekly texts and targeted lactation support based on galactogenesis and lactation milestones. The investigation team will monitor intervention fidelity by using the REDCap feature that allows the study team to view the date, time, length, and the number of times the participant accesses each module and completes the daily BF journal. The Project Manager will coordinate the study team to send participants text and follow-up phone calls at 1, 2, 3, 9, 12, and 18 weeks at a prescheduled time to encourage completion of the modules and for BSM intervention, address any BF concerns. After the first week, phone calls and encrypted text messages, depending on the participant preference, will be made by the research team to encourage BF data completion.

Participant Retention At enrollment, participants will be informed that payment will occur after each data collection point completion and if all data points are completed will receive a study completion bonus. To maintain contact and trust, the participants in both groups will receive monthly text links at 4, 8, 12, 16, 20, and 24 weeks, to modules highlighting normal infant development and age-appropriate play.

The sample size objective for the study is to recruit N = 222 participants who will be randomly assigned to the BSM or attention control study groups at a 1:1 ratio (111 per group). This objective provides 80 percent power (α =0.05, two-sided) to detect a standardized mean difference (Cohens d) of 0.39 or more between the BSM and attention control groups. It also provides 80 percent power to detect an odds ratio of 2.5 or more in exclusive BF between the two groups, assuming that the exclusive BF rate of the control group will be 10 percent higher than the national population rate in 2017 at 6, 9, 12, 18, and 24 weeks. These calculations account for "loss to follow-up" as high as 5% at 3 weeks and 25% at 24 weeks. The calculations reflect a conservative approach relative to the attrition rate of 6% that occurred at the 6-week time point in the pilot study and the 15-20% rate observed in many longitudinal intervention trials. In the pilot study, RM-ANCOVAs (with the baseline value of a measure as the covariate) revealed standardized mean differences larger than d = 0.39 for the main effect of the intervention on BNP intensity (d = 0.45), pain severity (d = 0.60), cumulative pain (d = 0.64), and BF self-efficacy (d = 0.48) cross the 1, 2, and 6 week time points. For BNP interference, the value of d was 0.39 at week 1, but smaller at weeks 2 and 6. Furthermore, the odds of exclusive BF in the intervention group is 2.9 times higher than the control group at 6 weeks, which is also higher than the hypothesized OR = 2.5. Therefore, the investigators are confident that the sample size goal will be sufficiently powered to detect intervention effects on key variables for SA1 and SA2.

Finally, the sample size estimate does not reflect the investigators' plans to conduct analyses based on repeated measurement of outcome variables at the 1, 2, 3, 6, 9, 12, 18, and 24 week time points (due to the dearth of information regarding 24-week outcomes). Generally, the inclusion of data for an outcome variable across additional time points marginally enhances statistical power, especially for testing main and interaction effects of intervention and time.

Eligibility criteria: Please reformat the Eligibility Criteria. The preferred format includes bulleted lists of inclusion and exclusion criteria as shown below.

Inclusion Criteria:

* women
* 18 - 45 years of age
* Gave birth \< 48 hours to a singleton infant \> 37 weeks gestational age
* Intend to BF
* Received standardized BF basics during their antenatal care
* Access to the internet via own smartphone or study provided smartphone
* Able to read and write English
* Assessed by lactation consultant during BF

Exclusion Criteria:

* \< 18 or \> 45 years of age
* History of significant mental health disorder (e.g., major depression, schizophrenia, or bipolar disorder) due to additional challenges in the capacity for self-management
* Skin conditions on nondominant forearm which could interfere with quantitative sensory testing
* Birth of an infant with medical complications or congenital anomalies

Primary outcomes:
measure: Breast and nipple pain severity measured by a self-report visual analogue scale from baseline to 24 weeks.
timeFrame: Baseline to 24 weeks
measure: Breast and nipple pain severity measured by Brief Pain Inventory pain intensity summary score from baseline to 24 weeks.
timeFrame: Baseline to 24 weeks
measure: Breast and nipple pain severity measured by Brief Pain Inventory pain interference summary score from baseline to 24 weeks.
timeFrame: Baseline to 24 weeks.
Secondary outcomes:
measure: Percentage of participants who continue to breastfeeding from baseline to 24 weeks via self-report
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Ruth F Lucas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lucas RF, McGrath JM. Clinical assessment and management of breastfeeding pain. Top Pain Manag. 2016;32(3):1-12.
citation: Lucas R, Bernier K, Perry M, Evans H, Ramesh D, Young E, Walsh S, Starkweather A. Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial. Res Nurs Health. 2019 Jun;42(3):176-188. doi: 10.1002/nur.21938. Epub 2019 Mar 5.
citation: Lucas R, Zhang Y, Walsh SJ, Evans H, Young E, Starkweather A. Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial. Nurs Res. 2019 Mar/Apr;68(2):E1-E10. doi: 10.1097/NNR.0000000000000336.
citation: Gallegos D, Russell-Bennett R, Previte J, Parkinson J. Can a text message a week improve breastfeeding? BMC Pregnancy Childbirth. 2014 Nov 6;14:374. doi: 10.1186/s12884-014-0374-2.
citation: Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.
citation: Subnis UB, Starkweather A, Menzies V. A current review of distraction-based interventions for chronic pain management. Eur J Integr Med. 2016;8(5):715-722. doi:10.1016/j.eujim.2016.08.162
citation: Litt MD, Tennen H. What are the most effective coping strategies for managing chronic pain? Pain Manag. 2015;5(6):403-6. doi: 10.2217/pmt.15.45. Epub 2015 Sep 24. No abstract available.