Trial Outcomes & Findings for Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma (NCT NCT05700747)

Results Overview

Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

At screening

Results posted on

2025-12-16

Participant Flow

16 patients were approached 11/16 were formally screened 6/11 were not interested/eligible 5/11 were interested and eligible 5/5 interested/eligible patients enrolled

Participant milestones

Participant milestones
Measure	Health Through Activity (HTA) Intervention Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Through Activity (HTA) Intervention n=5 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Age, Continuous	68.2 years STANDARD_DEVIATION 4.7 • n=6 Participants
Sex/Gender, Customized Males	3 Participants n=6 Participants
Sex/Gender, Customized Females	2 Participants n=6 Participants
Race/Ethnicity, Customized Race: White	5 Participants n=6 Participants
Race/Ethnicity, Customized Ethnicity: Non-Hispanic/Latino	5 Participants n=6 Participants

PRIMARY outcome

Timeframe: At screening

Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.

Outcome measures

Outcome measures
Measure	Health Through Activity (HTA) Intervention n=5 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Rate of Participant Enrollment	5 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Defined as the number of participants completing each of the three study assessments to number of participants enrolled. A completion rate of 85% will indicate feasibility.

Outcome measures

Outcome measures
Measure	Health Through Activity (HTA) Intervention n=5 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Assessment Completion Rate	5 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: Our outcome of Screening Rate depends on a denominator of "Number patients identified as potentially eligible." Therefore, this number is larger than the 5 participants who enrolled/started the study.

Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility

Outcome measures

Outcome measures
Measure	Health Through Activity (HTA) Intervention n=16 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Screening Rate	11 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: Our outcome of Eligibility Rate depends on a denominator of "Number screened." Therefore, this number is larger than the 5 participants who enrolled/started the study.

Number patients screening positive \& eligible / Number screened. Eligibility rate is influenced by how many people in the clinical population are experiencing disability. Based on our pilot study, expected rate to be at least 35%.

Outcome measures

Outcome measures
Measure	Health Through Activity (HTA) Intervention n=11 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Eligibility Rate	5 Participants

SECONDARY outcome

Timeframe: Up to 3 months

Defined as at least 75% of participants complete all six sessions of Health Through Activity (HTA) and if the mean number of sessions is greater than or equal to 4.

Outcome measures

Outcome measures
Measure	Health Through Activity (HTA) Intervention n=5 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Intervention Completion Rate	5 Participants

SECONDARY outcome

Timeframe: Up to 4 months

Population: 5/5 participants engaged in one-on-one semi-structured qualitative interviews following completion of intervention which allowed us to gauge overall participant experiences/satisfaction within the study and intervention. Unfortunately, a protocol deviation (reported to the IRB) resulted in the 7-item satisfaction survey not being included in the data collection materials. This measure will not be collected as participants had already completed the program and study will be closed to enrollment.

Assessed by the Satisfaction survey which is a 7-item survey that is rated on a 5-point Likert scale. Any item on the Satisfaction survey that generates a mean score of \< 4 will trigger consideration of modification to the HTA program.

Outcome measures

Outcome measures
Measure	Health Through Activity (HTA) Intervention n=5 Participants Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.
Participant Satisfaction Participants felt well supported by the interventionists	5 Participants
Participant Satisfaction Participants described feeling connected to the interventionists.	3 Participants
Participant Satisfaction Optimism and openness of interventionists kept participants engaged	3 Participants
Participant Satisfaction Participants felt the program structure was both effective and adaptable to their needs	5 Participants
Participant Satisfaction Participants identified areas of growth	5 Participants
Participant Satisfaction The program catalyzed participants to stay engaged, take action, and reflect on progress	5 Participants
Participant Satisfaction Suggestion to tailor messaging/advertising for better clarity of target audience.	1 Participants
Participant Satisfaction Suggestion to highlight that the program can be adapted to various performance levels	2 Participants
Participant Satisfaction Suggestion to explain why program addresses a wide range of health aspects vs going deep on one	3 Participants

Adverse Events

Health Through Activity (HTA) Intervention

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

Kathleen Lyons

MGH Institute of Health Professions

Phone: 617-643-5372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place