Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01901 | Registry Identifier | NCI, Clinical Trials Reporting Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Usual Care) | Experimental | Patients receive usual care only, without any additional interventions. |
|
| Group II (Usual Care plus LEF-SCP) | Experimental | 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. |
|
| Group III (Usual Care plus LEF-SCP plus Follow-Up) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | Undergo usual care only |
| |
| Usual Care plus LEF-SCP |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Following 3 weeks of the LEF-SCP sessions |
| 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. | Following 3 weeks of motivational interviewing sessions |
| 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). | at 12 months post-intervention |
| 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. | at 12 months post-intervention |
| Preliminary Efficacy of the LEF-SCP (Self-Efficacy) |
Not provided
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jie Deng, PhD, RN | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40773982 | Derived | Deng J, Murphy BA, Andersen LP, McMenamin E, Lukens JN, Cohn JC, Rajasekaran K, Quinn RJ, Spinelli BA, Lin A. Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot randomized controlled trial. Oral Oncol. 2025 Sep;168:107556. doi: 10.1016/j.oraloncology.2025.107556. Epub 2025 Aug 6. | |
| 36348346 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Usual Care) | Participants received usual care. |
| FG001 | Group II (Usual Care Plus LEF-SM Program) | Participants received usual care and LEF-SM Program. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Usual Care) | Patients receive monthly automated system telephone call for 12 months. Usual Care: Undergo usual care only |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Following 3 weeks of the LEF-SCP sessions |
|
Adverse event data were collected for 12 months.
No adverse event was reported during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Usual Care) | Patients receive monthly automated system telephone call for 12 months. Usual Care: Undergo usual care only |
Not provided
Not provided
This was a pilot study with the small number of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jie Deng, PhD, PI | University of Pennsylvania School of Nursing | 215-573-2393 | jiedeng@nursing.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2020 | Feb 27, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008209 | Lymphedema |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos |
|
| Usual Care plus LEF-SCP plus Follow-up | Other | 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 |
|
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.
| at 12 months post-intervention |
| Deng J, Lukens JN, Cohn JC, McMenamin E, Murphy B, Spinelli BA, Murphy N, Steinmetz AK, Landriau MA, Lin A. Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies. Trials. 2022 Nov 8;23(1):927. doi: 10.1186/s13063-022-06804-w. |
| 31882012 | Derived | Deng J, Dietrich MS, Murphy B. Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):775. doi: 10.1186/s13063-019-3819-0. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 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 |
|
|
| 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. | Posted | Count of Participants | Participants | Following 3 weeks of motivational interviewing sessions |
|
|
|
| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | at 12 months post-intervention |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | at 12 months post-intervention |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | at 12 months post-intervention |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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 | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |