Symptom Management for Rural-Urban Cancer Survivors and Caregivers

NCT05360498 | Completed

• 1 other identifier: 35164
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

Brief Summary

As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. The post-treatment period can present new challenges for many survivors as they encounter communication gaps in the transition from oncology to primary care, leaving unmet needs for information and management of lingering symptoms. The role of informal caregivers remains important during this post-treatment period and psychosocial interventions that meet the needs (e.g., information, symptom management) of both members of the dyad are highly valuable to caregivers and survivors. Many geographic and social determinants of health care use (e.g., distance to specialty care centers, available primary care providers, and public transportation) make access to care and adherence to recommended healthcare guidelines difficult for survivors and caregivers, especially those who reside in rural areas. Rural residents with cancer and their caregivers during the post-treatment period are underrepresented in symptom management research. To address the unmet needs (e.g., information, symptom management) of cancer survivors and their caregivers after cancer treatment, this team has developed, tested, and investigated two telephone delivered interventions for survivors and their caregivers: Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C).

Conditions

Cancer; Cancer Survivors; Informal Caregivers; Psychological Distress

Keywords

Cancer; Caregivers; Rural; Urban; Symptom Management; Psychosocial Oncology; Telephone Intervention

Outcome Measures

Primary Outcomes (2)

• Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms

  Symptoms will be measured using the General Symptom Distress Scale (GSDS), which is an instrument that allows a quick assessment of symptoms. It evaluates 15 symptoms such as: depression, anxiety, pain, shortness of breath, nausea, vomiting, diarrhea, constipation, fatigue, cough, poor appetite, sleep difficulties, swelling in hands and feet, difficulty concentrating, and headaches. Participants indicate the presence of each symptom and rate their severity on a scale of 0-10; 0= not experiencing this symptom, 1=mildly distressing to 10=extremely distressing.

  The GSDS will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.

• Change in Depression and Anxiety of Survivors' and Caregivers'

  To obtain more detail and precision in the measurement of depressive and anxiety symptoms, the PROMIS-short forms 8: depression and anxiety will be administered

  The PROMIS forms will be administered at baseline and two exit interviews at weeks 17 and 24.

Secondary Outcomes (2)

• Change in Survivors' and Caregivers' health services use: Unscheduled and scheduled visits

  These service use will be measured at baseline, week 17 and week 24.

• Survivors' and Caregivers' health services use: The American Society of Clinical Oncology Survivorship Guidelines

  Week 24

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Adaptive Need-based Sequence

Behavioral: Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C)

Attention control

ACTIVE COMPARATOR

This group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention.

Behavioral: NCI Brochure

Interventions

NCI Brochure BEHAVIORAL

The attention control arm will receive an NCI brochure: Facing Forward: Life After Cancer Treatment. This group will also get weekly calls for 16 weeks and complete two exit interviews. The NCI brochure will not be address, the purpose of these calls will only be to record participant's symptoms throughout the study. These calls will take about 10 minutes or less.

Attention control

Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) BEHAVIORAL

This group will get weekly calls for 16 weeks and two follow-up assessments. Participants will be asked to rate their symptoms on a 0-10 scale at each call. This group will receive the SMSH, a printed evidence-based self-care management handbook with specific modules, that will be directed to use for symptoms rated 4 or higher on a 0-10 scale. For symptoms ≥7, participants will be asked to report the symptom to their provider. At each weekly call, participants will be asked: if they tried symptom self-management strategies and, if yes, which strategies were used. These calls will take 10-15 minutes. If during 8 weeks of SMSH, either the survivor or caregiver have distress (symptoms 4 or greater on a 0-10 scale) for any two consecutive weeks during weeks 2-8, TIP-C will be added for the dyad for 8 weeks. The addition of TIP-C can start between weeks 4 and 9. Dyads will continue the SMSH in addition to the TIPC. TIP-C calls will take 35-45 minutes.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• within 4 weeks of completing or within 2 years of having completed cancer treatment with curative intent
• able to perform basic activities of daily living
• cognitively oriented to time, place, and person (recruiter determined)
• able to speak and understand English or Spanish
• access to a telephone
• has a caregiver who can be any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
• age 18 or older
• able to speak and understand English or Spanish
• telephone access
• not currently receiving counseling and/or psychotherapy
• not currently treated for cancer

You may not qualify if:

• Less than 18 years of age
• Diagnosis of psychotic disorder
• Nursing home resident
• Bedridden
• Currently receiving counseling and/or psychotherapy
• Less than 18 years of age
• Currently treated for cancer to preserve the distinguishability of "survivor" and "caregiver"
• Currently receiving counseling and/or psychotherapy

Sponsors & Collaborators

• American Cancer Society, Inc.: collaborator
• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chris Segrin, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 4, 2022
• Study Start: August 22, 2022
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Quality assurance and data analysis will be done periodically throughout the study.
• 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)