Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management

NCT03743415 | Completed Results

• 2 other identifiers: 1804501501R01CA224282
• Study Type: interventional
• Target: 908
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

psychosocial oncology; symptom management

Outcome Measures

Primary Outcomes (2)

• Symptom Severity Index- Comparison of Two Groups Created by First Randomization

  Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 1-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.

  Weeks 1-13 and week 17

• Symptom Severity Index- Comparison of Two Groups Created by Second Randomization

  Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 5-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.

  Weeks 5-13 and week 17

Secondary Outcomes (4)

• Depressive Symptoms- Comparison of Two Groups Created by First Randomization

  Week 13 and week 17

• Depressive Symptoms- Comparison of Two Groups Created by Second Randomization

  Week 13 and week 17

• Anxiety Symptoms- Comparison of Two Groups Created by First Randomization

  Week 13 and week 17

• Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization

  Week 13 and week 17

Study Arms (2)

Handbook

EXPERIMENTAL

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.

Behavioral: Handbook

TIP-C plus Handbook

EXPERIMENTAL

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.

Behavioral: TIP-C plus Handbook

Interventions

Handbook BEHAVIORAL

see arm/group descriptions

Also known as: Symptom Management and Survivorship Handbook

Handbook

TIP-C plus Handbook BEHAVIORAL

see arm/group descriptions

Also known as: Telephone Interpersonal Counseling plus Handbook

TIP-C plus Handbook

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85721, United States

Location

Related Publications (3)

• Warner 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 DERIVED

• Badger 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 DERIVED

• Badger 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

The larger than planned number of survivor-caregiver dyads with survivors responding to SMSH alone resulted in larger than planned number of participants in the first randomization and smaller number in the second randomization. There was a larger than planned number of responders to SMSH alone after 4 weeks.

Results Point of Contact

• Title: Terry Badger, PhD
• Organization: University of Arizona College of Nursing

tbadger@arizona.edu

520-626-6058

Study Officials

• Terry Badger, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Follow-up data collectors will be blind to the arm of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: November 16, 2018
• Study Start: January 16, 2019
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Anticipate later part of 2022
• Access Criteria: Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.

Locations

US (1)