Advanced Malignant Solid Neoplasm
Conditions
Brief summary
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer or a serious life-limiting illness. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual well-being, and mood in caregivers of patients with advanced cancer or a serious life-limiting illness.
Detailed description
PRIMARY OBJECTIVES: I. Determine feasibility as measured by total number of caregivers enrolled in 2 years (modification to extend study another year), adherence (75% of the enrolled participants will complete at least 6 of the 8 MCP groups). II. Determine acceptability as measured by satisfaction with the research process, as measured by the Was It Worth It (WiWi 2.0) questionnaire. III. To evaluate preliminary efficacy of group MCP-C for personal meaning as measured by Life Attitude Profile-Revised (LAP-R), spiritual wellbeing as measured by Functional Assessment of Chronic Illness Therapy (FACIT) Spiritual Well-Being Scale (SWBS), depression and anxiety symptoms as measured by Hospital Anxiety and Depression Scale (HADS), meaning in caregiving as measured by Attitudes Towards Caregiving Scale (ATCS), social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Questionnaire (FSSQ), benefit finding as measured by Benefit Finding Scale (BFS). IV. Determine participants' perceptions of their experience with the intervention, including potential benefits they experienced, which components had the greatest impact, and whether they would suggest any changes to the intervention. OUTLINE: Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study. After completion of study intervention, caregivers are followed up at 2 months.
Interventions
BEHAVIORALBehavioral Counseling
Participate in MCP-C
OTHERDiscussion
Participate in virtual group discussions
OTHERHealth Promotion and Education
Receive reading exercises and workbook materials
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>= 18 years * English fluency * No diagnosed severe cognitive impairment * Caregiver of a patient with a diagnosis of advanced, solid tumor cancer (stage III/stage IV), caregivers supporting a patient with a serious life-limiting illness * Provide written (paper or electronic) informed consent * Ability to complete questionnaire(s) by themselves or with assistance * Patient baseline distress score \>= 4/10 * Have ability to utilize the technology to participate in virtual groups
Exclusion criteria
* As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded * Other psychological co-morbidities such as untreated schizophrenia, bipolar disease * Cognitive impairment likely to interfere with participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention | Up to 1 year | Feasibility will be measured by numbers and percentages of participant recruitment, enrollment, accrual, and retention of participants in the MCP-C intervention. Findings will be summarized using estimates and corresponding 95% confidence intervals. |
| Acceptability of MCP-C intervention | 4 months (2 months post intervention) | Acceptability will be measured by the Was It Worth It (WIWI) Questionnaire. The WIWI consists of 7 questions, 3 answered with yes/no/uncertain, two answered on a 3-point scale (i.e., improved, stayed the same, or got worse), one open-ended/fill-in-the-blank question, and one yes/no question. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in personal meaning - LAP-R | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | The Life Attitude Profile-Revised (LAP-R) is a 48-item scale that measures a person's life attitude and meaning in life. The LAP-R is scored on a 7-point Likert scale, with a minimum score of 30 and a maximum score of 210. A higher score indicates a greater sense of meaning in life and a more positive attitude towards life. |
| Change in spiritual well-being - FACIT-Sp-12 | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp-12), a 12-item self-report measure with a total score range of 0-48, with higher scores indicating a greater level of spiritual well-being. items are answered on a scale of 0-4 where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, and 4=Very much. |
| Changes in anxiety and depression - HADS | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | Change in anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item self-rated questionnaire with depression and anxiety subscales both ranging from 0 to 21, categorized as: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Items are answered on a scale of 0-3 with varying responses for each question (e.g., very much/quite a lot/not very much/not at all or often/sometimes/not often/very seldom). |
| Change in attitude toward caregiving - ATCS | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | Change in attitude toward caregiving will be assessed using the Attitudes Towards Caregiving Scale ( ATCS), a 43-item 5-point Likert-type measure of ways caregivers find meaning through caregiving. The ATCS yields an overall (range 43-215) and three subscale \[loss/powerlessness (range 19-96), provisional meaning (range 19-96), and ultimate meaning (range 5-25)\] scores, with higher scores indicating higher overall meaning. Items are answered with one of 5 responses: strongly agree, agree, undecided, disagree, or strongly disagree. |
| Change in perception of social support - Duke-UNC FSSQ | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | Change in perception of social support will be assessed using the Duke/University of North Caroling (UNC) Functional Social Support Questionnaire (FSSQ), an 8-item measure of social support that generates a total score (range 0-44). Higher scores generally indicate a higher degree of satisfaction related to social support. Items are answered on a scale of 5-1 where 5=as much as I would like; 4=almost as much as I would like; 3=some, but would like more; 2=less than i would like, and 1=much less than I would like. |
| Change in benefit-finding - BFS | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | Change in perception of benefit will be assessed using the Benefit Finding Scale (BFS), a 17-item measure of perceived benefits adapted from Behr's Positive Contributions Scale for breast cancer, modified for caregiving. It yields a total score (range 17-85) with higher scores indicating greater benefit finding. Items are answered with one of 5 responses: not at all, a little bit, somewhat, quite a bit, or very much. |
| Change in Cancer Support Source Caregiver-18+ score | Baseline, 8 weeks (post intervention), 4 months (2 months post intervention) | The Cancer Support Source-Caregiver (CSS-Caregiver) is an 18-item questionnaire used to assess demands of cancer caregiving. Participants rate items of concern on a scale of 0 (not at all) to 4 (very seriously). A higher score indicates an item is of greater concern. Higher overall scores indicate higher levels of stress. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeirdre R. Pachman, MD
Mayo Clinic in Rochester
Outcome results
None listed