A Brief Psychological Intervention to Improve Emotional Well-Being During Neoadjuvant Therapy for Pancreatic Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This clinical trial tests how well a psychosocial oncology intervention during neoadjuvant therapy works for patients with pancreatic cancer that has not spread to other parts of the body (localized). Chemotherapy and/or radiation therapy is often recommended prior to surgeryf or patients with pancreatic cancer; this is known as neoadjuvant therapy (NT). The primary advantages of NT include: reducing the size of the cancer mass and/or reducing the spread of cancer, to improve the likelihood of getting all the cancer during surgery, and because receiving chemotherapy after pancreas surgery can be challenging. Other research has shown that NT can lead to improved survival and a lower rate of the cancer returning. Despite these positive effects, NT can be associated with significant physical and emotional side effects. To prepare patients for future surgery and maintain health during chemotherapy and/or radiation, prehabilitation is often recommended. This can include nutritional and physical therapy to help with physical health. An oncology (cancer) psychosocial intervention during NT may be feasible and helpful to patients with localized pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥ 18 years of age

Newly diagnosed patients with localized pancreatic ductal adenocarcinoma (PDAC) presenting to Ohio State University Wexner Medical Center-Comprehensive Cancer Center (OSUMC-CCC)

Plans to initiate neoadjuvant therapy prior to surgical resection

Neoadjuvant therapy (NT) and/or surgery may occur at another facility

Disqualifiers

Prisoners

Persons unable to provide consent

Patients unlikely to undergo surgical resection following NT based on anatomical or performance status considerations

Confirmed or presumed metastatic disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Interview

    Other intervention

    Ancillary studies

  • Nutritional Therapy

    Procedure/Surgery

    Attend nutritional appointments

  • Physical Therapy

    Procedure/Surgery

    Attend physical therapy appointments

  • Psychosocial Care

    Behavioral

    Receive psychosocial care

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Health Services Research (psychosocial care)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Feasibility and acceptability of the psychosocial oncology intervention

Will be defined as the proportion of enrolled patients who complete the intervention and report that it was acceptable. Will define the incorporation of psychosocial oncology into prehab as feasible and acceptable if \>= 70% of enrolled participants agree.

Time frame
Up to 1 year

Secondary outcomes

1

Changes in health-related quality of life for patients with hepatobiliary cancer

Will be assessed using Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G. (FACT-G) is a 27-item questionnaire designed to measure four domains of health related quality of life(HRQOL) in cancer patients: Physical, social, emotional, and functional well-being.. Respondents use a five-point Likert-type scale ranging from 0 to 4, with higher scores reflecting a better quality of life or fewer symptoms. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.

Time frame
Up to 1 year
2

Changes in mood for patients with hepatobiliary cancer

Will be assessed using the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item instrument used to measure anxiety and depression in medically ill patients frequently used to identify depression in cancer patients. Scores are totaled for both depression and anxiety symptoms and range from 0 to 21 with a higher score indicating worse symptoms. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.

Time frame
Up to 1 year
3

Changes in worry for patients with hepatobiliary cancer

Will be assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 20-item measure of worry. Scores range from 16 to 80 with higher scores indicative of higher levels of worry. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.

Time frame
Up to 1 year
4

Changes in uncertainty for patients with hepatobiliary cancer

Will be assessed using the Intolerance of Uncertainty Scale (IUS-12) which Measures a component of worry and anxiety associated with discomfort due to the possibility of future events. Respondents use a five-point Likert-type scale ranging from 1 to 5, with higher scores reflecting a higher intolerance of uncertainty in patients. The data will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Differences will be assessed using linear mixed models accounting for within-subject correlations and individual differences.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

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