Goal Attainment Scaling for Peripheral Neuropathy

Overseen By Alice Ye, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with peripheral neuropathy, a nerve issue often caused by chemotherapy, in focusing on what matters most to them. It examines how setting personal goals, using Goal Attainment Scaling, can enhance overall care, moving beyond merely treating the disease. Participants will be divided into two groups: one will receive support for setting goals, while the other will not. Individuals who have experienced bothersome nerve pain most days for the past three months and reside in the Houston area might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that prioritize personal well-being.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on behavioral aspects rather than medication changes.

What prior data suggests that this behavioral trial is safe for participants?

Research has shown that Goal Attainment Scaling is safe for use in healthcare. This method involves setting personal goals for patients and tracking their progress. As it is neither a drug nor a surgery, it lacks the usual side effects associated with those treatments.

This approach helps patients focus on what is most important to them and work towards those goals. Since it involves setting and tracking personal goals, no negative effects have been reported. This makes it a well-accepted option for managing conditions like peripheral neuropathy, which involves nerve damage that can cause pain or numbness.

In summary, Goal Attainment Scaling offers a safe and personalized way to help people achieve their health goals without the worry of traditional medical side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Goal Attainment Scaling (GAS) approach for peripheral neuropathy because it focuses on personalized goal setting and progress tracking, which is different from standard treatments that often emphasize symptom management. Unlike medications that generally target pain relief or nerve repair, GAS empowers patients to set and achieve specific personal goals, potentially improving quality of life. This method could lead to more tailored care, helping patients address their unique challenges with the condition.

What evidence suggests that Goal Attainment Scaling is effective for peripheral neuropathy?

Studies have shown that Goal Attainment Scaling (GAS) effectively measures how well patients achieve their personal health goals. This method is beneficial because it allows patients to set their own targets and track progress, making it highly personalized. Research indicates that GAS can accurately detect small changes in a patient's condition, whether improvements or declines. Although specific data for peripheral neuropathy is not yet available, GAS has been successfully used in other conditions, such as with breast cancer survivors, to measure progress. In this trial, participants will be divided into two groups: one receiving Goal Encouragement and the other with No Goal Encouragement. Overall, GAS helps tailor care to what matters most to each patient, potentially leading to better health outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Alice Ye, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals experiencing peripheral neuropathy, which often causes numbness, tingling, or pain in the limbs. Participants should be interested in a personalized approach to manage their condition by setting and working towards their own health goals.

Inclusion Criteria

I haven't received cancer treatment recently or have been on a stable treatment for 3 months.

Provision of signed and dated electronic informed consent form

Access to smartphone and internet for participating in a technology-based intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in behavioral interventions aimed at identifying personal values and goals

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Goal Attainment Scaling

Trial Overview The intervention being studied is Goal Attainment Scaling (GAS), a method that helps patients set personal health-related goals and track their progress over time. The study focuses on shifting from traditional disease treatment to individualized patient care.

How Is the Trial Designed?

Group I: No Goal Encouragement Experimental Treatment 1 Intervention

Eligible participants will be identified using electronic health record

Group II: Goal Encouragement Experimental Treatment 1 Intervention

Eligible participants will be identified using electronic health record

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The Overall Neuropathy Limitations Scale (ONLS) shows high inter-rater reliability and a strong correlation with established measures of disability and physical health, indicating it is a reliable tool for assessing peripheral neuropathy activities.

The ONLS demonstrates better content validity and less ceiling effect compared to the Overall Disability Sum Score (ODSS), making it potentially more effective for both clinical practice and research in evaluating neuropathy limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modified peripheral neuropathy scale: the Overall Neuropathy Limitations Scale. Graham, RC., Hughes, RA.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06736600

Study Details | NCT06736600 | Patient-identified Values as ... The quaternary objective will be to assess a novel measure of CIPN outcomes called the Individual Neuropathy Report Card against current common CIPN measures.

2. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-5-2025-e8029

Goal Attainment Scaling for Peripheral Neuropathy Goal Attainment Scaling is unique because it focuses on setting personalized goals for patients and measuring their progress towards these goals, ...

3. research.aota.org research.aota.org/ajot/article/78/Supplement_2/7811500037p1/25326/Measuring-Progress-in-Breast-Cancer-Survivors-With

Measuring Progress in Breast Cancer Survivors With ... This presentation will discuss our study results showing that goal attainment scaling (GAS) is a feasible and sensitive measure of functional ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10965877/

A systematic review of goal attainment scaling ... Goal attainment scaling (GAS), an established individualized, patient-centred outcome measure, is used to capture the patient's voice.

5. researchgate.net researchgate.net/publication/5959888_Goal_attainment_scaling_Current_methodological_challenges

Goal attainment scaling: Current methodological challenges Over 14% of the simulated cases showed a magnitude of difference in change scores between the ordinal and linear-based GAS scores greater than ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK580224/

Diagnosis and Treatment of Painful Diabetic Peripheral ... - NCBI Diabetic neuropathies are the most common chronic complications of diabetes, with an estimated lifetime prevalence exceeding 50% in people with diabetes.

7. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S252/157552/12-Retinopathy-Neuropathy-and-Foot-Care-Standards

12. Retinopathy, Neuropathy, and Foot Care: Standards of ... Diabetic retinopathy is a highly specific neurovascular complication of both type 1 and type 2 diabetes, with prevalence strongly related to both the duration ...

8. physio-pedia.com physio-pedia.com/Goal_Attainment_Scaling

Goal Attainment Scaling 1. Identify goals Interview patient and/or caregivers to identify a) problem areas and b) priority areas · 2.Weight goals Done by patient ranking goals by ...

9. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(20)30500-4/fulltext

Neuropathic pain in children: Steps towards improved ... Neuropathic pain in children can be severe and persistent, difficult to recognise and manage, and associated with significant pain-related disability.