Clinical trial · Interventional
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Handbook | Behavioral | — | UNRESOLVED |
| TIP-C plus Handbook | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Handbook
- description
- The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook is available in English and Spanish. Each weekly call will begin with the symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors will be referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms will be assessed. During weekly calls to caregivers, the caregivers will be notified of symptoms above threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms are assessed, a summary of survivors' symptoms provided. Calls will last about 10 minutes.
- interventionNames
- Behavioral: Handbook
- type
- EXPERIMENTAL
- label
- TIP-C plus Handbook
- description
- Each survivor and caregiver will receive one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol is the same for both survivor and caregiver. During weekly contacts, the counselors target social support behaviors using interpersonal communications techniques. Counselors can personalize the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks will be Handbook only.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- DERIVEDWarner EL, Traslavina Jimenez J, Sikorskii A, Segrin C, Crane T, Badger TA. Feedback on Adapting Interventions for AYA Cancer Survivors' and Caregivers' Psychological Distress, Symptom Management, and Health Care Use. J Adolesc Young Adult Oncol. 2026 Apr;15(2):134-142. doi: 10.1177/21565333251369687. Epub 2025 Dec 11. PMID 40828682
- DERIVEDWarner EL, Sikorskii A, Cunicelli N, Badger T, Segrin C, Morrill KE, Rainbow J. Employment Productivity and Cancer-Related Psychological Symptoms Among Adult Cancer Dyads. J Occup Environ Med. 2025 May 1;67(5):e294-e301. doi: 10.1097/JOM.0000000000003334. Epub 2025 Jan 30. PMID 39905918
- DERIVEDBadger T, Segrin C, Crane TE, Chalasani P, Arslan W, Hadeed M, Given CW, Sikorskii A. A sequential multiple assignment randomized trial of symptom management for cancer survivors during treatment and their informal caregivers. Support Care Cancer. 2024 Jul 18;32(8):523. doi: 10.1007/s00520-024-08734-6. PMID 39023547
- DERIVEDBadger T, Segrin C, Crane T, Morrill K, Sikorskii A. Social determinants of health, psychological distress, and caregiver burden among informal cancer caregivers of cancer survivors during treatment. J Psychosoc Oncol. 2024;42(3):333-350. doi: 10.1080/07347332.2023.2248486. Epub 2023 Aug 23. PMID 37609806