Fibrosis, Head and Neck Cancer, Lymphedema
Conditions
Brief summary
This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care activities for managing chronic swelling and tough/tight tissues in the head and neck region.
Detailed description
PRIMARY OBJECTIVES: I. To complete development of a self-care program focusing on lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors (LEF-self-care program \[SCP\]) with the goal of improving LEF associated outcomes when compared to usual care alone. (Stage I) II. To determine the feasibility of a program of LEF-SCP with or without follow-up to usual care for HNC survivors with LEF, specifically to: 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction. (Stage II) III. To determine if the LEF-SCP with or without follow-up enhances self-efficacy and adherence compared to usual care in HNC survivors with LEF. (Stage II) IV. To determine the preliminary efficacy of the LEF-SCP with or without follow-up as compared to usual care for the following outcomes: 1) LEF progression; 2) symptom burden; and 3) functional status. (Stage II) OUTLINE: Project Stage I: Patients undergo a training session with the study lymphedema therapist and review the educational manual and videos for the development of all three components of the LEF self-care program. Project Stage II: Patients are randomized to 1 of 3 groups. GROUP I: Patients will receive usual care only, without any additional interventions. GROUP II: Patients undergo LEF-SCP training comprising of motivational interview (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. GROUP III: 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. After completion of study, patients are followed up at 3, 6, 9, and 12 months.
Interventions
OTHERUsual Care
Undergo usual care only
OTHERUsual 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
OTHERUsual 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
Sponsors
American Cancer Society, Inc.
National Cancer Institute (NCI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post HNC primary treatment * No evidence of cancer (NED) * No more than 6 months after completion of initial lymphedema therapy for head and neck lymphedema * \> 18 years of age * Ability to understand English in order to complete questionnaires * Able to complete the onsite training and home self-care activities for LEF management * Able to provide informed consent
Exclusion criteria
• Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) | Following 3 weeks of the LEF-SCP sessions | 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. |
| Feasibility of the LEF-SCP (Motivational Interviewing Sessions) | Following 3 weeks of motivational interviewing sessions | Feasibility 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. |
| Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF) | at 12 months post-intervention | Change 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). |
| Preliminary Efficacy of the LEF-SCP (Symptom Burden) | at 12 months post-intervention | Change 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. |
| Preliminary Efficacy of the LEF-SCP (Self-Efficacy) | at 12 months post-intervention | Change 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I (Usual Care) Patients receive monthly automated system telephone call for 12 months.
Usual Care: Undergo usual care only | 20 |
| Group II (Usual Care Plus LEF-SCP) 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 | 20 |
| Group III (Usual Care Plus LEF-SCP Plus Follow-Up) 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 | 19 |
| Total | 59 |
Baseline characteristics
| Characteristic | Group I (Usual Care) | Total | Group III (Usual Care Plus LEF-SCP Plus Follow-Up) | Group II (Usual Care Plus LEF-SCP) |
|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 7.5 | 60 years STANDARD_DEVIATION 9.8 | 60 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 53 Participants | 18 Participants | 15 Participants |
| Region of Enrollment United States | 20 participants | 59 participants | 19 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 49 Participants | 17 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Feasibility of the LEF-SCP (Motivational Interviewing Sessions)
Feasibility 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.
Time frame: Following 3 weeks of motivational interviewing sessions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group II (Usual Care Plus LEF-SCP) | Feasibility of the LEF-SCP (Motivational Interviewing Sessions) | 20 Participants |
| Group III (Usual Care Plus LEF-SCP Plus Follow-Up) | Feasibility of the LEF-SCP (Motivational Interviewing Sessions) | 16 Participants |
Primary
Feasibility of the LEF-SCP (Self-Care Skill Training Sessions)
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.
Time frame: Following 3 weeks of the LEF-SCP sessions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group II (Usual Care Plus LEF-SCP) | Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) | 20 Participants |
| Group III (Usual Care Plus LEF-SCP Plus Follow-Up) | Feasibility of the LEF-SCP (Self-Care Skill Training Sessions) | 18 Participants |
Primary
Preliminary Efficacy of the LEF-SCP (Self-Efficacy)
Change 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.
Time frame: at 12 months post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group II (Usual Care Plus LEF-SCP) | Preliminary Efficacy of the LEF-SCP (Self-Efficacy) | 1.26 score on a scale |
| Group III (Usual Care Plus LEF-SCP Plus Follow-Up) | Preliminary Efficacy of the LEF-SCP (Self-Efficacy) | 4.71 score on a scale |
| Group 3 | Preliminary Efficacy of the LEF-SCP (Self-Efficacy) | 4.85 score on a scale |
Primary
Preliminary Efficacy of the LEF-SCP (Symptom Burden)
Change 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.
Time frame: at 12 months post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group II (Usual Care Plus LEF-SCP) | Preliminary Efficacy of the LEF-SCP (Symptom Burden) | -0.15 score on a scale |
| Group III (Usual Care Plus LEF-SCP Plus Follow-Up) | Preliminary Efficacy of the LEF-SCP (Symptom Burden) | -0.73 score on a scale |
| Group 3 | Preliminary Efficacy of the LEF-SCP (Symptom Burden) | -0.53 score on a scale |
Primary
Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF)
Change 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).
Time frame: at 12 months post-intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group II (Usual Care Plus LEF-SCP) | Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF) | -0.11 score on a scale |
| Group III (Usual Care Plus LEF-SCP Plus Follow-Up) | Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF) | -2.35 score on a scale |
| Group 3 | Preliminary Efficacy of the LEF-SCP (Total Severity of External LEF) | -2.25 score on a scale |