Maximizing Quality of Life After Cancer Through Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development
About this trial
Treatment for head and neck cancer (HNC) often includes cisplatin chemotherapy and radiation. This treatment causes hearing loss and trouble swallowing in 70% of patients. If untreated, these symptoms increase stress and lower quality of life for survivors. Veterans with HNC usually get help for swallowing. However, damage to the hearing and balance systems-known as ototoxicity-is often missed or only addressed when it becomes very severe. To fill this gap, the investigators plan a clinical trial at two VA sites. The investigators compare the usual swallowing therapy alone to a new, more comprehensive program. This new program includes:
1. the standard swallowing therapy, 2. proactive management to protect hearing and balance or manage problems that can't be prevented, and 3. other rehabilitation services based on a tele-oncology nurse's assessment. The hearing and balance intervention features quick screening tests and validated questionnaires to identify early signs of damage. These are given during cancer or radiation treatment visits to maximize convenience for the patient. Audiologists review these results remotely using tele-health technology. The investigators will also use new tools to predict and spot hearing problems that are personalized for each patient. The audiologist works closely with the patient and the care team to arrange further help if needed.
The tele-oncology nurse checks for other rehabilitation needs using a screening tool validated in Veterans, shares this information with the team, and advises patients about recommended care.
The investigators expect the results to show that managing hearing loss with swallowing therapy while improving care coordination for rehabilitation reduces survivors' stress and improves well-being compared to swallowing therapy alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with head and neck malignancy within the past 60 days;
prescribed a treatment plan at participating site that includes at least 1 dose of a cisplatin-based chemotherapy, or at least one dose of radiotherapy and/or surgery;
prescribed Intensive Dysphagia Therapy (IDT) at the participating site;
sufficient fluency in written English to be able to complete the study patient reported outcome questionnaires.
Disqualifiers
distant metastasis at enrollment;
diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment;
prior or planned total laryngectomy;
prior or planned cochlear implant;
Trial design
Design model
Parallel
Treatments tested in this trial
TIMELY REHAB
Other interventionParticipants randomized to the TIMELY REHAB arm receive a coordinated cancer rehabilitation program that includes: Intensive Dysphagia Therapy (IDT): Participants receive the VA's standard-of-care swallowing therapy for patients with head and neck cancer. Ototoxicity Management: This comprehensive program provides ototoxicity screening and referral services to support auditory and balance health. It incorporates patent-pending, patient-specific ototoxicity forecasting and identification models alongside chairside high-frequency audiometry, delivered using store-and-forward tele-audiology. Screening for Other Rehabilitation Needs: Additional assessments are conducted to address a range of rehabilitation concerns, such as pain, mental health, and mobility. These are delivered via telehealth visits by an advanced practice oncology nurse using the VA-validated Cancer Rehabilitation (CaRe) Screen, supporting a holistic intervention consistent with the VA's Whole Health model.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: TIMELY REHABExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Stress from cancer and its treatment
This will be measured with the Impact of Event Scale-Revised (IES-R.) This is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. Items correspond directly to 14 of the 17 DSM-IV symptoms of PTSD. Respondents are asked to identify a specific stressful life event (in this case, cancer diagnosis and care) and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed.
Time frame
Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatmentSecondary outcomes
1
Management of dysphagia
Measurements will include psychosocial changes secondary to swallowing function (MD Anderson Dysphagia Inventory).
Time frame
Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment2
Perceived impairment of hearing loss
The Abbreviated Profile of Hearing Aid Benefit \& Hearing Handicap Inventory for Adults (APHAB) is a self-report questionnaire that can be used to assess the frequency of hearing problems in various listening situations. It includes 4 subscales: ease of communication, reverberation, background noise, and aversiveness to sounds. Global scores are calculated as the average of the EC, BN, and RV subscale scores. Higher scores reflect a greater frequency of perceived hearing difficulties.
Time frame
Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment3
Psychosocial impacts of hearing loss
The Revised Hearing Handicap Inventory (RHHI) is a self-report questionnaire designed to measure the psychosocial impact of hearing loss on a patient's life. The RHHI assesses how hearing problems affect: social interactions, emotional well-being, daily activities, and quality of life. The total score is the sum of all 18 items, and a score \>6 is suggestive of a hearing-related psychosocial problem.
Time frame
Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment4
Psychosocial impacts of tinnitus
The Tinnitus Primary Function Questionnaire (TPFQ) focuses on activities impacted by tinnitus, including: thoughts and emotions, hearing, sleep, and concentration. There are 12 items and each is rated on a 0-100 scale. The global score is a sum of all 12 items and higher scores indicate more perceived impairment from tinnitus.
Time frame
Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatmentOther outcomes
1
Uptake of audiology services
Audiology service use will be assessed using the electronic medical record to calculate the number of diagnostic audiology visits, hearing aid assessments, fitting of new hearing aids, hearing technology adjustments, falls assessments, and visits for hearing or balance rehabilitation at each testing location. The rate of audiological service visits will be used to indicate the uptake of services with a higher rate indicating better uptake.
Time frame
Assessed within one month prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment2
Positive VA CaRe screen result rate indicating need for new referral
Data from the electronic medical record will be used to tally the number and proportion of screened visits with ≥1 "yes" response, the number of "yes" responses per screening item, as well as the proportion of positive screens that resulted in a completed rehabilitation visit or an associated physiatrist consult, within 14 days.
Time frame
Assessed within one month prior to treatment, 3 months post-, and 12-18 months post-initiation of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
William S. Middleton Memorial Veterans Hospital
Collaborator
Durham VA Health Care System
Collaborator
Source ClinicalTrials.gov
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