Clinical trial NCT05360498: Symptom Management for Rural-Urban Cancer Survivors and Caregivers
Official title: Need-based Adaptive Symptom Management to Address Social Determinants of Health at Individual, Interpersonal, and Community Levels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Cancer Survivors
Informal Caregivers
Psychological Distress
Keywords: Cancer
Caregivers
Rural
Urban
Symptom Management
Psychosocial Oncology
Telephone Intervention
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-05-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria for the survivors:

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.

Inclusion criteria for the caregivers:

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 for the survivors:

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

Exclusion criteria for caregiver:

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

Primary outcomes:
measure: Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms
timeFrame: The GSDS will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.
measure: Change in Depression and Anxiety of Survivors' and Caregivers'
timeFrame: The PROMIS forms will be administered at baseline and two exit interviews at weeks 17 and 24.
Secondary outcomes:
measure: Change in Survivors' and Caregivers' health services use: Unscheduled and scheduled visits
timeFrame: These service use will be measured at baseline, week 17 and week 24.
measure: Survivors' and Caregivers' health services use: The American Society of Clinical Oncology Survivorship Guidelines
timeFrame: Week 24
Other outcomes:
Locations:
city: Kingman
country: United States
facility: KRMC WL Nugent Cancer Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Chris Segrin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: