Trial Outcomes & Findings for Managing Cancer and Living Meaningfully (NCT NCT04646213)

NCT ID: NCT04646213

Last Updated: 2024-03-13

Results Overview

Number of potential participants consented and enrolled

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2024-03-13

Participant Flow

Participant milestones

Measure	Therapy psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Overall Study STARTED	14
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Therapy psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Managing Cancer and Living Meaningfully

Baseline characteristics by cohort

Measure	Therapy n=14 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Number of potential participants consented and enrolled

Outcome measures

Measure	Therapy n=14 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Recruitment for CALM Consented	14 Participants
Recruitment for CALM Enrolled	14 Participants
Recruitment for CALM Started intervention	12 Participants

PRIMARY outcome

Timeframe: 3 months

Number of participants completing CALM sessions

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Completion of CALM Sessions	9 Participants

PRIMARY outcome

Timeframe: 4 months

Number of participants completing post-session surveys

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Post-session Assessment Completion	10 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants that completed a follow-up survey

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Follow-up Assessment Completion	4 Participants

PRIMARY outcome

Timeframe: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

Population: Of the 12 intervention initiators

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.

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Satisfaction With CALM Sessions	4.6 units on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

Population: Of the 12 intervention initiators

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.

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Helpfulness of CALM Sessions	4.6 score on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

Population: Of the 12 trial initiators

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.

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Relevance of CALM	4.6 score on a scale Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

Population: of the 12 trial initiators

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.

Outcome measures

Measure	Therapy n=12 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Utility of CALM	4.5 score on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: 3 month - one timepoint

Population: of the 9 intervention completers

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.

Outcome measures

Measure	Therapy n=9 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Intervention Satisfaction	4.5 score on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: 3 month timepoint

Population: of the 9 intervention completers

Rating of the likelihood of recommending the program to others.

Outcome measures

Measure	Therapy n=9 Participants psychotherapeutic intervention Managing Cancer and Living Meaningfully (CALM) Therapy: 6 sessions of individualized CALM therapy
Number of Participants Likely to Recommend the Program to Others Will Recommend	9 Participants
Number of Participants Likely to Recommend the Program to Others Will not Recommend	0 Participants

Adverse Events

Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ashlee Loughan

Virginia Commonwealth University

Phone: 804-828-4178

Email: ashlee.loughan@vcuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place