Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Condition: Breastfeeding, Exclusive; Pain, Acute; Maternal Distress; Parent-Child Relations; Self Efficacy
MeSH terms: Acute Pain
Study type: Interventional

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.
    

Intervention name(s): The BSM Intervention; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The BSM intervention entailed a daily electronic journal for monitoring BF and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support and to promote personalized goal-setting and problem-solving, and hyperlinks to eight uniform BNP educational modules (knowledge and skills) and online resources. 1. Fundamentals of BF (FBF), 2. Deep breathing (DB), 3. BNP non-pharmacological strategies (BNPS), 4. Guided imagery (GI), 5. Pain neurophysiology specifically related to BF (PN-BF), 6. Catastrophizing, 7. Stress reactivity, and 8. Common pumping issues and interventions (CPI).; The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breastfeeding, pain, self-efficacy