Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Fibrosis

Dilatation, Pathologic

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Quality of Life

Anal Cancer

Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy

Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy

special tampon with a diameter of 28mm

patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy

standard tampon with a diameter of 12-13mm

Nathalie Arians, MD

Matthias Haefner, MD

Jürgen Debus, Prof. Dr.

Adriane Hommertgen

A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \<20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \>35-49% as Grade 3 and a reduction \>/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.

The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study

during and after radiotherapy, clinical symptoms are assessed and graded

during and after radiotherapy, clinical symptoms are assessed and graded according to the CTC AE v5.0 criteria

daily assessment of the clinical feasibility of daily use of a special tampon

patients will be instructed to use a vaginal dilator 3 times a week, at each follow-up visit patients are asked about the frequency of vaginal dilator use

EORTC-QLQ30/-ANL27 questionnaires are used to assess quality of life

Juergen Debus

Principal Ivestigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

patients who will be under routine hospital care as well as Mindfulness-Based Stress Reduction (MBSR) program The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.

Female cancer patients who will be under routine hospital care

The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.

Mindfulness-based stress reduction intervention

Breast cancer is a significant issue in Egypt, affecting a large number of women and impacting their psychological well-being. Younger patients and those undergoing adjuvant therapy or radiotherapy are particularly susceptible to psychological distress. Psychological counseling and support groups can help improve patients' quality of life and social functioning. Hope plays a crucial role in the treatment process, as it is associated with positive outcomes and serves as a protective mechanism against stress and disease. Mindfulness-Based Stress Reduction (MBSR) is an intervention that can reduce stress and depression in cancer patients. It involves cultivating awareness of the present moment and has positive effects on quality of life. Investigating the impact of MBSR on psychological distress and hope in women undergoing radiotherapy for breast cancer is important for providing effective support during treatment.

The aim of this study is to:

Examine the effect of the Mindfulness-Based Stress reduction intervention on psychological distress and hope among female patients undergoing radiotherapy for breast cancer.

RESEARCH HYPOTHESIS Female patients undergoing radiotherapy for breast cancer who attend Mindfulness-Based Stress reduction intervention sessions exhibit higher levels of hope and lower levels of psychological distress compared to those who receive conventional hospital treatment.

Adult female patients with post-mastectomy to decrease the confounding factors.

Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer

Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer: A Randomized Control Trial

The Baer et al. (2006) scale is a 39-item questionnaire designed to measure different aspects of mindfulness. It uses a five-point Likert scale, with responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.

Observing subscale: Measures the tendency to notice or attend to internal and external phenomena.

Describing subscale: Assesses the ability to label observed phenomena, such as thoughts and emotions.

Acting with awareness subscale: Reflects the extent to which individuals engage with full awareness in their current experience or activity.

Non-judging subscale: Assesses nonjudgmental awareness of current experience without evaluation.

Non-reactivity subscale: Measures the ability to notice internal phenomena without reacting to them.

It is a self-reported scale developed by Lovibond, \& Lovibond, (1995). The three subscales of the DASS 21 measure the negative emotional states of depression, anxiety, and stress (i.e., nervous tension and irritability, which are factorially distinct from depression and anxiety). Participants scored questions such as "I thought that as a person I wasn't worth much" (from "0" =did not apply to me at all to "3" =applied very much to me or most of the time). A total score out of 21 was determined for each subscale and then multiplied by 2 to be equivalent to the full-scale DASS scores. At least 10 (depression), 8 (anxiety), and 15 (stress) ratings indicated psychological distress levels for each item. Distress severity was categorized as mild, moderate, severe, and very severe.

The Herth Hope Index (HHI) is a clinical-setting adaptation form of the Herth Hope Scale (HHS). This scale was developed by Herth, at Minnesota State in the USA (Herth, 1992). It is composed of 12 items, which are rated on a four points Likert scale. The responses ranged from 1 (strongly disagree) to 4 (strongly agree). Items 3 and 6 are reversed in their score. The twelve items are summed to obtain a total score that ranges from 12 to 48, with a higher score equating to a higher level of hope. The instrument contains three factors, namely temporality \& future, positive readiness \& expectancy, and finally interconnectedness with self and others.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy	NCT04094454	Anal Cancer	special tampon ... standard tampon...	18 Years -	University Hospital Heidelberg
Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer	NCT06025799	Breast Cancer F...	Mindfulness-bas...	-	Alexandria University
Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer	NCT06025799	Breast Cancer F...	Mindfulness-bas...	-	Alexandria University
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy	NCT04094454	Anal Cancer	special tampon ... standard tampon...	18 Years -	University Hospital Heidelberg

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