Symptom Management for Rural-Urban Cancer Survivors and Caregivers

NCT ID: NCT05360498

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 555 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2025-12-01

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).

Detailed Description

This randomized control trial will be composed of at least 106 survivors that are ending their treatment or within 2 years of having completed cancer treatment with curative intent and their informal caregivers. This study will include participants of diverse backgrounds (40% Latinx) from urban and rural (approximately 50% each) areas. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) or 2) Attention control. The participants will receive weekly phone calls during 16 weeks where the interventionist will utilize the General Symptom Management Scale (GSDS) to assess their symptoms and level of symptom distress. After the initial 8 weeks in the Handbook group, the survivor's and caregiver's symptom distress will be assessed. If either the survivor or caregiver indicate elevated psychological distress for any two consecutive weeks during weeks 2 through 8, there will be an addition of TIP-C to their Handbook intervention from weeks 8 through 16. The participants in the attention control group will receive a National Cancer Institute brochure: Facing Forward: Life After Cancer Treatment plus, 16 weekly calls to assess their symptoms. Regardless of randomization, all participants will complete a baseline call and two exit interviews at weeks 17 and 24.

The specific aims are to:

1. Determine if the adaptive need-based SMSH+TIP-C sequence results in improved outcomes compared to the attention control.

Hypothesis 1a. SMSH+TIP-C will result in lower psychological distress and summed severity index of 14 other symptoms (primary outcomes) over weeks 1-17 and 24, more appropriately scheduled and less unscheduled health services use (secondary outcomes) over weeks 1-24 for survivors and caregivers.

Hypothesis 1b. Improvements in primary and secondary outcomes will be partially mediated by 1) greater enactment of SMSH strategies in weeks 1-16 and 2) improved perceptions of social support and social isolation by week 17 for survivor and caregivers.

2. Test longitudinal (weeks 1-24) dyadic interdependence in primary and secondary outcomes of survivors and caregivers to determine if there are reciprocating effects between dyad members.

3. Explore if rural versus urban residence and associated Social Determinant of Health factors (e.g., ethnicity, socio-economic status [SES], age, insurance) moderate the effects of the SMSH+TIP-C intervention on primary and secondary outcomes and modify the strength of dyadic interdependence in these outcomes for survivors and caregivers.

The interventions will be delivered in English or Spanish, depending on the language preference of the participant.

Conditions

Cancer; Cancer Survivors; Informal Caregivers; Psychological Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Arm

Adaptive Need-based Sequence

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Attention control

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

Group Type: ACTIVE_COMPARATOR

NCI Brochure

Intervention Type: 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.

Interventions

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

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 Type: BEHAVIORAL

NCI Brochure

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. age 18 or older

2. within 4 weeks of completing or within 2 years of having completed cancer treatment with curative intent

3. able to perform basic activities of daily living

4. cognitively oriented to time, place, and person (recruiter determined)

5. able to speak and understand English or Spanish

6. access to a telephone

7. has a caregiver who can be any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.

1. age 18 or older

2. able to speak and understand English or Spanish

3. telephone access

4. not currently receiving counseling and/or psychotherapy

5. not currently treated for cancer

Exclusion Criteria

1. Less than 18 years of age

2. Diagnosis of psychotic disorder

3. Nursing home resident

4. Bedridden

5. Currently receiving counseling and/or psychotherapy

1. Less than 18 years of age

2. Currently treated for cancer to preserve the distinguishability of "survivor" and "caregiver"

3. Currently receiving counseling and/or psychotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Segrin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

35164

Identifier Type: -

Identifier Source: org_study_id