A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.
After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.
Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 or over;
As per self-report, a current caregiver to a patient with Stage III or IV solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative);
Experiences distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and an indication that this distress is associated with caregiving;
As per self-report, can read and understand English;
Disqualifiers
Participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional;
Engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Meaning-Centered Psychotherapy for Caregivers
BehavioralMCP-C is a stakeholder-informed, innovative, manualized intervention designed to assist caregivers to connect to a sense of meaning and purpose in life, despite the challenges of caregiving.
Supportive Psychotherapy for Caregivers
BehavioralStandard of care supportive psychotherapy
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Meaning-Centered Psychotherapy for CaregiversExperimental treatment 1 intervention
Group B: Supportive Psychotherapy for CaregiversActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with improved primary outcomes
Evaluate the efficacy of MCP-C versus SP-C in improving primary outcomes (i.e., sense of meaning in life, spiritual well-being) immediately post-treatment and explore maintenance in gains up to 1 year.
Time frame
Up to 1 year2
Life Attitude Profile-Revised (LAP-R)
Life Attitude Profile-Revised (LAP-R) - used to measure sense of meaning in life. The LAP-R is a 48-item instrument. Each item is rated on a 7-point Likert scale ranging from "strongly agree" to "strongly disagree." Full scale ranges from 30 to 210 with a higher score indicating a greater sense of meaning in life and a more positive attitude towards life.
Time frame
Up to 1 year3
FACIT Spiritual Well-Being Scale (SWBS)
The Spiritual Well-Being Scale (SWBS) - used to measure spiritual well-being. The SWBS is a 12-item instrument. Each item is scored from 1 to 5. Negatively worded items are reverse scored. The measure generates two sub-scales: Faith/Spirituality (0-16) and Meaning/Peace (0-32). Full scale ranges from 0 to 48. Higher scores indicate a greater sense of spiritual well-being.
Time frame
Up to 1 yearSecondary outcomes
1
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) - measures anxiety and depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating poorer health outcome.
Time frame
Up to 1 year2
Benefit Finding Scale (BFS)
Benefit Finding Scale (BFS) - measures benefit finding. The BFS is a 17-item instrument. Each item is scored from 1-5 (not at all, a little bit, somewhat, quite a bit, or very much). Full scale ranges from 17 to 85, with higher scores indicating greater benefit finding.
Time frame
Up to 1 year3
Caregiver Reaction Assessment (CRA)
Caregiver Reaction Assessment (CRA) - measures caregiver burden. The CRA is a 24-item instrument. Full scale ranges from 24 to 120, with higher scores indicating greater caregiving burden
Time frame
Up to 1 year4
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Duke-UNC Functional Social Support Questionnaire (FSSQ) - measures social support. The FSSQ is an 8-item instrument. Each item is scored 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. Full scale ranges from 0 to 44 with higher scores indicating a higher degree of satisfaction related to social support.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborator
University of Miami Sylvester Comprehensive Cancer Center
Collaborator
Source ClinicalTrials.gov