Clinical trial NCT03743415: Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
Official title: Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: psychosocial oncology
symptom management
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-16
Enrollment: 908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This project will determine which dyads require which intervention sequence: Handbook alone, Handbook alone stepped up with Telephone Interpersonal Counseling (TIP-C) based on demonstrated needs after giving Handbook alone 4 weeks of time, or an combined TIP-C+Handbook for the first 8 weeks then Handbook alone for 4 weeks. Dyads will be initially randomized to either Handbook alone or TIP-C+Handbook. If the survivor's depression or anxiety does not respond to Handbook alone at week 4, dyads will be re-randomized to the TIPC+Handbook or continue with Handbook alone. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Total duration is 17 weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative designs (e.g.,implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show promise in developing the sequences of evidence-based interventions for more efficient and individualized patient- and caregiver-centered care. The investigators will use findings from this study to create an algorithm for clinically meaningful decision making about symptom management for survivors and their caregivers to be tested in future implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.

Detailed description: Informal caregivers, typically family members or friends, provide more than half of the care needed for the 5.7 million cancer survivors (defined as individuals from diagnosis to end-of-life) in the United States, often with negative consequences to their health. Caregivers assist with the management of the survivor's symptoms such as fatigue, pain and insomnia, and others.Psychological distress (depression and anxiety) has been reported in at least 30% of survivors and their caregivers who are not always prepared for the task of symptom management. This research assists both the caregiver and survivor (the dyad in this study) to manage the survivor's cancer- and treatment-related symptoms and the distress of both members of the dyad in a sample of 298 survivors with elevated depression or anxiety and their 298 caregivers. Dyads will be recruited during the survivor's chemotherapy or targeted therapy for a solid tumor, a time when symptom burden and psychological distress are particularly high.

The investigators will use two evidence-based interventions extensively tested against active and passive controls in traditional randomized controlled trials (RCTs). While overall efficacy of these interventions has been established, individuals differ in their responses. When an intervention does not initially work, clinical logic is to either extend the timeframe or prescribe a different intervention. Yet, these alternatives are seldom tested and not evidence-based. The proposed project advances beyond a traditional RCT of testing fixed "one size fits all" interventions to the sequential multiple assignment randomized trial (SMART) design to build the evidence base for intervention sequencing that accounts for heterogeneity of responses.

The first intervention, a printed symptom management and survivorship handbook (Handbook) with strategies for self-management of symptoms common during chemotherapy will be given to both survivor and caregiver (the dyad). Handbook strategies, if successfully enacted, produce positive symptom responses for the survivor. However, psychological distress of the survivor or the caregiver may diminish the receipt and enactment of the Handbook strategies and also exacerbate the severity of other symptoms which, in turn, produces poor symptom responses. Research by this team has documented dyadic effects where survivors' psychosocial distress impacts that of the caregiver and vice versa. The survivor's and caregiver's distress exhibit similar trajectories. Therefore, the second intervention tested in sequencing is the 8-week telephone interpersonal counseling intervention (TIP-C) to manage psychological distress of the dyad.

The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.

The following specific aims will be tested.

1. Determine if dyads in the TIP-C+Handbook as compared to the Handbook alone group created by the first randomization will have: a) lower depression, anxiety, and summed severity of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of healthcare services (hospitalizations, urgent care or emergency department \[ED\] visits) during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and lower caregiver burden during weeks 13 and 17 (potential mediators).
2. Among non-responders to the Handbook alone after 4 weeks, determine if dyads in TIP-C+Handbook as compared to the Handbook alone group created by the second randomization will have better primary and secondary outcomes and potential mediators at weeks 5-12, 13, and 17.
3. Test the interdependence in survivors' and caregivers' primary and secondary outcomes.
4. Determine which characteristics of the dyad are associated with responses to the Handbook alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13 and 17 so as to determine tailoring variables for the decision rules of individualized sequencing of interventions in the future.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for the survivors are: 1) age 18 or older; 2) undergoing chemotherapy, hormonal therapy, or targeted therapy for a solid tumor cancer; 3) able to perform basic activities of daily living; 4) cognitively oriented to time, place, and person (determined by recruiter); 5) reporting severity of \>2 on depression or \>4 on anxiety using a 0-10 standardized scale; 6) able to speak and understand English or Spanish; 7) access to a telephone and 8) has a caregiver who can be in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.

Inclusion criteria for the caregivers are: 1) age 18 or older; 2) able to speak and understand English or Spanish; 3) access to a telephone; 4) not currently receiving counseling and/or psychotherapy; and 5) not currently treated for cancer.

Exclusion Criteria:

* Exclusion criteria are: 1) diagnosis of a psychotic disorder in the health record; 2) nursing home resident; 3) bedridden; 4) currently receiving counseling and/or psychotherapy.

Primary outcomes:
measure: Symptom Severity Index- Comparison of Two Groups Created by First Randomization
timeFrame: Weeks 1-13 and week 17
measure: Symptom Severity Index- Comparison of Two Groups Created by Second Randomization
timeFrame: Weeks 5-13 and week 17
Secondary outcomes:
measure: Depressive Symptoms- Comparison of Two Groups Created by First Randomization
timeFrame: Week 13 and week 17
measure: Depressive Symptoms- Comparison of Two Groups Created by Second Randomization
timeFrame: Week 13 and week 17
measure: Anxiety Symptoms- Comparison of Two Groups Created by First Randomization
timeFrame: Week 13 and week 17
measure: Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization
timeFrame: Week 13 and week 17
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Terry Badger, PhD
role: PRINCIPAL_INVESTIGATOR
References: