N/A
N=748
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03743415 ↗Enrolled (actual)
748
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Symptom Severity Index- Comparison of Two Groups Created by First Randomization — 26.28; 26.55; 12.02; 11.19 units on a scale — p=.81
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Handbook (Behavioral); TIP-C plus Handbook (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Severity Index- Comparison of Two Groups Created by First Randomization |
26.28; 26.55; 12.02; 11.19; 25.72; 26.30 | .81 |
| PRIMARY Symptom Severity Index- Comparison of Two Groups Created by Second Randomization |
33.67; 34.14; 14.50; 12.53; 37.84; 35.86 | .53 |
| SECONDARY Depressive Symptoms- Comparison of Two Groups Created by First Randomization |
12.90; 13.78; 10.48; 10.44; 13.60; 13.67 | .44 |
| SECONDARY Depressive Symptoms- Comparison of Two Groups Created by Second Randomization |
19.21; 19.17; 11.60; 13.60; 20.34; 21.24 | .98 |
| SECONDARY Anxiety Symptoms- Comparison of Two Groups Created by First Randomization |
48.98; 50.86; 47.72; 47.58; 49.11; 50.91 | .06 |
| SECONDARY Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization |
52.90; 54.31; 50.47; 49.92; 55.75; 55.48 | .45 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03743415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.