Trial Outcomes & Findings for Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis (NCT NCT03030859)
NCT ID: NCT03030859
Last Updated: 2024-04-11
Results Overview
Feasibility of the LEF-SCP was evaluated by number of participants that completed the self-care skill training sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Following 3 weeks of the LEF-SCP sessions
Results posted on
2024-04-11
Participant Flow
Participant milestones
| Measure |
Group I (Usual Care)
Participants received usual care.
|
Group II (Usual Care Plus LEF-SM Program)
Participants received usual care and LEF-SM Program.
|
Group III (Usual Care Plus LEF-SM Program Plus Follow-Up With a Lymphedema Therapist)
Participants received usual care plus LEF-SM Program plus follow-up with a lymphedema therapist
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
19
|
|
Overall Study
COMPLETED
|
19
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Baseline characteristics by cohort
| Measure |
Group I (Usual Care)
n=20 Participants
Patients receive monthly automated system telephone call for 12 months.
Usual Care: Undergo usual care only
|
Group II (Usual Care Plus LEF-SCP)
n=20 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
Usual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
|
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
n=19 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
Usual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
60 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
60 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
59 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Following 3 weeks of the LEF-SCP sessionsFeasibility of the LEF-SCP was evaluated by number of participants that completed the self-care skill training sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.
Outcome measures
| Measure |
Group II (Usual Care Plus LEF-SCP)
n=20 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
Usual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
|
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
n=19 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
Usual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
|
Group 3
Usual Care Plus LEF-SCP Plus Follow-Up
|
|---|---|---|---|
|
Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)
|
20 Participants
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: Following 3 weeks of motivational interviewing sessionsFeasibility of the LEF-SCP was evaluated by number of participants that completed the motivational interviewing sessions (at least 2 out of 3 sessions). This measure was applicable to Group II and Group III only.
Outcome measures
| Measure |
Group II (Usual Care Plus LEF-SCP)
n=20 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
Usual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
|
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
n=18 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
Usual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
|
Group 3
Usual Care Plus LEF-SCP Plus Follow-Up
|
|---|---|---|---|
|
Feasibility of the LEF-SCP (Motivational Interviewing Sessions)
|
20 Participants
|
16 Participants
|
—
|
PRIMARY outcome
Timeframe: at 12 months post-interventionChange in total severity of external LEF from baseline to 12 months post-intervention. A larger change in this score means more reduction in the severity of external LEF, External LEF is measured by HN-LEF Assessment Criteria. The total external LEF severity score is calculated by summing the severity score of each site (total 9 sites, severity score ranging from 0-27). For each site, the severity of LEF includes no LEF (=0), mild (=1), moderate (=2), and severe (=3).
Outcome measures
| Measure |
Group II (Usual Care Plus LEF-SCP)
n=19 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
Usual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
|
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
n=20 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
Usual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
|
Group 3
n=16 Participants
Usual Care Plus LEF-SCP Plus Follow-Up
|
|---|---|---|---|
|
Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)
|
-0.11 score on a scale
Interval -1.01 to 0.8
|
-2.35 score on a scale
Interval -3.51 to -1.19
|
-2.25 score on a scale
Interval -3.91 to -0.59
|
PRIMARY outcome
Timeframe: at 12 months post-interventionChange in symptom burden score from baseline to 12 months post-intervention. A larger change in this score means decreased symptom burden. Symptom burden is assessed by Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI). Higher scores (score ranging from 0-5) indicate increased symptom burden. There are 7 subscales and only one subscale (soft tissue and neurologic toxicity) score is reported here.
Outcome measures
| Measure |
Group II (Usual Care Plus LEF-SCP)
n=19 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
Usual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
|
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
n=20 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
Usual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
|
Group 3
n=16 Participants
Usual Care Plus LEF-SCP Plus Follow-Up
|
|---|---|---|---|
|
Preliminary Efficacy of the LEF-SCP (Symptom Burden)
|
-0.15 score on a scale
Interval -0.49 to 0.19
|
-0.73 score on a scale
Interval -1.21 to -0.24
|
-0.53 score on a scale
Interval -1.06 to -0.01
|
PRIMARY outcome
Timeframe: at 12 months post-interventionChange in self-efficacy score from baseline to 12 months post-intervention. A larger change in this score means increased self-efficacy. Self-efficacy is assessed by Perceived Medical Condition Self-Management Scale (PMCSMS) (8-item). Higher scores (score ranging from 8-40) indicate greater self-efficacy.
Outcome measures
| Measure |
Group II (Usual Care Plus LEF-SCP)
n=19 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
Usual Care plus LEF-SCP: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
|
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
n=17 Participants
Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
Usual Care plus LEF-SCP plus Follow-up: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
|
Group 3
n=13 Participants
Usual Care Plus LEF-SCP Plus Follow-Up
|
|---|---|---|---|
|
Preliminary Efficacy of the LEF-SCP (Self-Efficacy)
|
1.26 score on a scale
Interval -1.33 to 3.85
|
4.71 score on a scale
Interval 1.21 to 8.21
|
4.85 score on a scale
Interval 0.12 to 9.57
|
Adverse Events
Group I (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II (Usual Care Plus LEF-SCP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group III (Usual Care Plus LEF-SCP Plus Follow-Up)
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
Jie Deng, PhD, PI
University of Pennsylvania School of Nursing
Phone: 215-573-2393
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place