Standard chemotherapy protocols for adjuvant \& neoadjuvant treatment for different types of solid malignancies

Chemotherapy

khawla loubani, PhD

Abed Agbarya, MD

The purpose of this study is to examine changes in perceived daily performance and executive functioning following chemotherapy in individuals with non-central nervous system cancers.

Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer

Articles are planned for publication of the study protocol and final study results.

The questionnaire will include the following details: age (years), education (years), sex (female, male), marital status (married, not married, divorced, widow), number of children, work status (employed, not employed, independent), dominant hand (right, left), socioeconomic level (income level), type/stage of cancer (1,2,3), disease characteristics (e.g., size of the tumor, number of affected lymph nodes), details of treatments received (e.g., types of surgery chemotherapy regimens, date of chemo commencement, number of cycles completed).

Canadian Occupational Performance Measure - COPM assesses perceived daily performance and performance satisfaction with meaningful daily activities.

During the pre-chemotherapy assessment, participants will identify up to five activities that they prioritize as meaningful for them. Each of these activities is then rated on a 10-point scale for perceived performance (1=not able to do at all, 10=able to do extremely well) and similarly for satisfaction with performance. The final scores of the COPM are the average scores for total performance and for satisfaction (higher scores indicate better performance or satisfaction with performance). During the post-chemotherapy assessment, the participants will rate the same activities they prioritized in the pre-chemotherapy assessment.

Assesses daily participation in recreational and social activities, movement within the community, and degree of comfort the individual has in his/her role in the family and with other relationships.

Assesses dual tasking by performing two tasks concurrently

A performance-based assessment that examines the influence of subtle executive function difficulties on person's ability to perform a multiple-step activity.

FACT-Cognitive Function questionnaire Version 3 assesses cognitive functioning in individuals with cancer. For assessing cognitive self-efficacy we will use the cognitive self-abilities subscale (CogPCA) of the questionnaire, which includes 7 statements with responses given on a 5-point Likert scale (from 0, never; to 4, several times a day). The score range= 0-28 with higher scores indicating higher difficulties.

Emotional Well-Being will be assessed by the emotional well-being subscale from the FACT-G (General) questionnaire (https://www.facit.org/). The EWB scale includes six statements with responses given on a 5-point Likert scale (from 0, not at all; to 4, very much). The score range= 0-24 with higher scores indicating higher emotional deficits.

Fatigue will be assessed by the FACIT Fatigue questionnaire FACIT-F, Version 4 which includes 13 statements with responses given on a 5-point Likert scale (from 0, not at all; to 4, very much). The score range= 0-52 with higher scores indicating more fatigue.

Open ended questions will be presented on a sheet of paper and the participants will be asked to write their answers bellow together with the accessor. Reporting does not include a score on a scale.

Tel Aviv University

Bnai Zion Medical Center

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

1-on-1 interview + Questionnaires, Part 1 of Study

1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes.

Interview

Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.

Survey

Diane C. Bodurka, MD, BS

Objectives:

The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer.

The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers.

The Secondary Aims are:

To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.

PART 1:

Interview:

If you agree to take part in this study, you will be interviewed about what it is like to have ovarian cancer and any symptoms that you may have experienced. This will be a 1-on-1 interview with the study doctor or a member of the study staff. It will take place during 1 of your regularly scheduled, standard of care clinic visit and should take about 30 minutes to complete.

The interview will be digitally recorded. The electronic recording of the interview will be given a code number and stored on a password-protected computer at M. D. Anderson. No identifying information will be directly linked to your interview recording. Only the researcher in charge of the computer will have access to the code numbers and be able to link the interview recording to you.

Questionnaires:

After the interview, you will also complete a symptom questionnaire, a quality-of-life questionnaire, and a demographic questionnaire that asks questions about your age, race, and marital status. You will complete the questionnaires after the interview during the same clinic visit. It should take about 10 minutes to complete all 3 questionnaires.

You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.

The questionnaires will also be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.

Length of Study:

After you have completed the interview and the questionnaires, your participation on this study will be over.

Additional Information:

Any information about your symptoms that is collected as part of this study is for research purposes only. All study materials, including the interview recording and questionnaires, will only be used for the purposes of this study and will be destroyed after the study results have been reported.

If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.

This is an investigational study.

Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.

PART 2:

Questionnaires:

If you agree to take part in this study, you will complete the following:

1. A symptom questionnaire, 2 quality-of-life questionnaires, and a demographic questionnaire that asks questions about your age, race, and marital status. It should take about 20 minutes to complete all 4 questionnaires.
2. About 1 to 5 days after you complete the first set of questionnaires, you will be asked to complete a questionnaire either through phone interview with the study staff or through a mail-in survey . If you complete the questionnaire by mail-in survey, the study staff will give you a copy of the questionnaire and a stamped pre-addressed envelope. The questionnaire will take 5-10 minutes to complete.

You should contact the study doctor or study nurse right away if at any time you are experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate them on the symptom questionnaire.

The questionnaires will be given a code number and stored in a locked file cabinet at M. D. Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.

Opinion Questionnaire:

If you are one of the first 20 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

After you have completed the questionnaires, your participation on this study will be over.

Additional Information :

Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.

If you rate a symptom as severe on the symptom questionnaire, a study staff member will ask you if you have already told, or plan to tell your regular care doctor or nurse about the symptom. If you have not already told you regular care doctor or nurse, a study staff member will tell your regular care doctor or nurse about the symptom for you.

This is an investigational study.

Up to 128 participants will take part in this study. All will be enrolled at MD Anderson and Lyndon B. Johnson General Hospital.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer	NCT05599698	Cancer	Chemotherapy	18 Years - 75 Years	Bnai Zion Medical Center
M. D. Anderson Symptom Inventory - Ovarian Cancer	NCT01037751	Ovarian Cancer	Interview Survey	18 Years -	M.D. Anderson Cancer Center

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