Advanced Malignant Solid NeoplasmNCT06630351
Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients With Serious Illness
A study testing Behavioral Counseling, Discussion and Health Promotion and Education in people with Advanced Malignant Solid Neoplasm, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Solid Neoplasm
- What is being tested?
- Behavioral Counseling, Discussion and Health Promotion and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Group Meaning-Centered Psychotherapy for Caregivers of Patients With Serious Life-Limiting Illness
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Advanced Malignant Solid Neoplasm
- Being tested
- Behavioral Counseling, Discussion, Health Promotion and Education, Interview, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral CounselingBehavioural
Also called Behavior Counseling, Behavioral Psychotherapy
Participate in MCP-C
DiscussionOther
Also called Discuss
Participate in virtual group discussions
Health Promotion and EducationOther
Receive reading exercises and workbook materials
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (MCP-C) | Experimental | 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. Receives: Behavioral: Behavioral Counseling; Other: Discussion; Other: Health Promotion and Education; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention
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.
Measured: Up to 1 year
Acceptability of MCP-C 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.
Measured: 4 months (2 months post intervention)
Secondary outcomes (7)
Change in personal meaning - LAP-R
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.
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in spiritual well-being - FACIT-Sp-12
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.
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Changes in anxiety and depression - HADS
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).
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in attitude toward caregiving - ATCS
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.
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in perception of social support - Duke-UNC FSSQ
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.
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in benefit-finding - BFS
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.
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in Cancer Support Source Caregiver-18+ score
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.
Measured: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start12 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie S. McAndrew, PhD, RN, Mayo Clinic
- Investigators
- Deirdre R. Pachman, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630351
- Sponsor's protocol ID
- 24-004250
- Other IDs
- NCI-2024-07626, 24-004250
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Meaning-Centered Psychotherapy for Caregivers of Patients With Serious Life-Limiting Illness
- ClinicalTrials.gov ID
- NCT06630351
- Acronym / sponsor ID
- 24-004250
- Conditions
- Advanced Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (MCP-C) | Experimental | Behavioral: Behavioral Counseling, Other: Discussion, Other: Health Promotion and Education, Other: Interview, Other: Questionnaire AdministrationCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral CounselingAlso: Behavior Counseling, Behavioral PsychotherapyParticipate in MCP-C | Behavioural | Supportive Care (MCP-C) |
| DiscussionAlso: DiscussParticipate in virtual group discussions | Other | Supportive Care (MCP-C) |
| Health Promotion and EducationReceive reading exercises and workbook materials | Other | Supportive Care (MCP-C) |
| InterviewAncillary studies | Other | Supportive Care (MCP-C) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (MCP-C) |
Primary outcome
Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change in personal meaning - LAP-R
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in spiritual well-being - FACIT-Sp-12
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Changes in anxiety and depression - HADS
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in attitude toward caregiving - ATCS
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in perception of social support - Duke-UNC FSSQ
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in benefit-finding - BFS
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Change in Cancer Support Source Caregiver-18+ score
Time frame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deirdre R. Pachman, MD principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Counseling, Discussion and Health Promotion and Education in people with Advanced Malignant Solid Neoplasm, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.