MoodCALMNCT04646213

Managing Cancer and Living Meaningfully

A study testing Managing Cancer and Living Meaningfully (CALM) Therapy in people with Mood and Cancer Brain, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mood, Cancer Brain
What is being tested?: Managing Cancer and Living Meaningfully (CALM) Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 3 Dec 2020to 14 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

have a confirmed malignant brain cancer diagnosis via histopathology
be a minimum of 2 weeks post-surgical resection or biopsy (if applicable)
be primarily English speaking
be age 18-89
obtain >20 on the Telephone Interview for Cognitive Status (TICS)
have current elevated depression or death anxiety symptoms
have a reliable internet connection to participate in the Zoom therapy sessions

Who cannot join

Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction
inability to meet with interventionist via an electronic device for telehealth intervention sessions
inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients

Read the detailed description

In this study, participants will be asked to do the following things:

Complete ~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life.
Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names.
Complete weekly ~5 minute online surveys after each session on satisfaction with the program.
Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

Conditions: Mood, Cancer Brain
Being tested: Managing Cancer and Living Meaningfully (CALM) Therapy
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Managing Cancer and Living Meaningfully (CALM) TherapyBehavioural
6 sessions of individualized CALM therapy

Study groups in NCT04646213
Study group	Role	What they receive
Therapy	Experimental	psychotherapeutic intervention Receives: Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment for CALM
Number of potential participants consented and enrolled
Measured: 1 day
Completion of CALM Sessions
Number of participants completing CALM sessions
Measured: 3 months
Post-session Assessment Completion
Number of participants completing post-session surveys
Measured: 4 months
Follow-up Assessment Completion
Number of participants that completed a follow-up survey
Measured: 6 months
Satisfaction With CALM Sessions
Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.
Measured: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Helpfulness of CALM Sessions
Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness.
Measured: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Relevance of CALM
Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness.
Measured: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Utility of CALM
Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness.
Measured: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Intervention Satisfaction
Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.
Measured: 3 month - one timepoint
Number of Participants Likely to Recommend the Program to Others
Rating of the likelihood of recommending the program to others.
Measured: 3 month timepoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202014 Feb 2022

First posted27 Nov 2020
Study start3 Dec 2020
Primary completion14 Sep 2021
Study completion14 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MoodStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe 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: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04646213
Sponsor's protocol ID: MCC-20-16440
Other IDs: HM20020308
Acronym: CALM
Status last verified: Mar 2024
First submitted: 20 Nov 2020
Last updated: 13 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

Publications

Loughan AR, Willis KD, Braun SE, Rodin G, Lanoye A, Davies AE, Svikis D, Mazzeo S, Malkin M, Thacker L. Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. J Neurooncol. 2022 May;157(3):447-456. doi: 10.1007/s11060-022-03988-8. Epub 2022 Apr 18.
PubMed 35437687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mood trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients
ClinicalTrials.gov ID: NCT04646213
Acronym / sponsor ID: CALM / MCC-20-16440
Conditions: Mood, Cancer Brain
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: American Cancer Society, Inc.
Study start: 3 Dec 2020 (actual)
Primary completion: 14 Sep 2021 (actual)
Study completion: 14 Feb 2022 (actual)
First posted: 27 Nov 2020 (actual)
Results: Posted 13 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In this study, participants will be asked to do the following things:

Complete ~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life.
Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names.
Complete weekly ~5 minute online surveys after each session on satisfaction with the program.
Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Therapy	Experimental	Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapypsychotherapeutic intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

have a confirmed malignant brain cancer diagnosis via histopathology
be a minimum of 2 weeks post-surgical resection or biopsy (if applicable)
be primarily English speaking
be age 18-89
obtain >20 on the Telephone Interview for Cognitive Status (TICS)

Key exclusion criteria (3 listed)

Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction
inability to meet with interventionist via an electronic device for telehealth intervention sessions
inability to provide informed consent

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
Managing Cancer and Living Meaningfully (CALM) Therapy6 sessions of individualized CALM therapy	Behavioural	Therapy

Primary outcome

Recruitment for CALM
Time frame: 1 day
Number of potential participants consented and enrolled
Completion of CALM Sessions
Time frame: 3 months
Number of participants completing CALM sessions
Post-session Assessment Completion
Time frame: 4 months
Number of participants completing post-session surveys
Follow-up Assessment Completion
Time frame: 6 months
Number of participants that completed a follow-up survey
Satisfaction With CALM Sessions
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.
Helpfulness of CALM Sessions
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness.
Relevance of CALM
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness.
Utility of CALM
Time frame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness.
Intervention Satisfaction
Time frame: 3 month - one timepoint
Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.
Number of Participants Likely to Recommend the Program to Others
Time frame: 3 month timepoint
Rating of the likelihood of recommending the program to others.

Results and safety

Results posted to the registry on 13 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Therapy	14	9

Primary outcome: Recruitment for CALM

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Therapy n = 14
Consented	14
Enrolled	14
Started intervention	12

Primary outcome: Completion of CALM Sessions

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Therapy n = 12
Value	9

Primary outcome: Post-session Assessment Completion

Time frame: 4 months. Count of participants. Unit: Participants

Measure	Therapy n = 12
Value	10

Primary outcome: Follow-up Assessment Completion

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Therapy n = 12
Value	4

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapy	0 of 0	0 of 0	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35437687Loughan AR, Willis KD, Braun SE, Rodin G, Lanoye A, Davies AE, Svikis D, Mazzeo S, Malkin M, Thacker L. Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. J Neurooncol. 2022 May;157(3):447-456. doi: 10.1007/s11060-022-03988-8. Epub 2022 Apr 18.
Individual participant dataSharing planned: No. Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

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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. This study is not recruiting at the moment.

Ashlee Loughan, PhD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Managing Cancer and Living Meaningfully (CALM) Therapy in people with Mood and Cancer Brain, run by Virginia Commonwealth University at 1 site 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 7 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recruitment for CALM (time frame: 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646213, which also lists 1 linked publication.

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 13 Mar 2024.